FDA Device recall Z-2269-2019
SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectiona…
- FDA Device
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectiona… by Siemens Medical Solutions Usa, citing potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2269-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-03 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
Reason
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Identifiers
| code_info | Serial Numbers: 83904 83931 83834 83746 83811 83915 83801 83767 83880 83899 83852 83798 83837 83878 8383…Serial Numbers: 83904 83931 83834 83746 83811 83915 83801 83767 83880 83899 83852 83798 83837 83878 83832 83871 83903 83808 83763 75475 83732 83752 83382 83845 83846 83749 83847 83786 83842 83775 83796 94801 83768 83909 83875 83859 83928 83826 83754 83913 83896 83790 83824 83898 83810 83886 83758 83901 83914 83823 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2269-2019%22
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